European regulations

The overall philosophy behind granting a marketing authorization for a new drug is broadly similar in the USA and Europe. There are, however, major differences in the systems by which these philosophies are implemented in the two regions.

The EU is currently composed of 27 member states and a total population of 480 million (compared with 250 million in the USA and 125 million in Japan, the other two world pharmaceutical markets). The total European pharmaceutical market value stands at €70 billion, representing almost 33 per cent of world sales (the US and Japanese figures are 31 per cent and 21 per cent respectively). Annual expenditure on European pharmaceutical R&D stands at about €17 billion.

Prominent within the EU organizational structure is the European Commission. The major function of the European Commission is to propose new EU legislation and to ensure enforcement of existing legislation. European drug law, therefore, comes under the auspices of the Commission.

Two forms of legal instrument can be issued from the centralized European authorities: a 'regulation' and a 'directive'. A regulation is a strong legal instruction that, once passed, must be implemented immediately, and without modification, by national governments. A directive is a looser legal term, and provides an individual member state with 18 months to translate the flavour of that law into national law. Pharmaceutical law within the EU has been shaped by both directives and regulations, as discussed later.

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